FDA 510(k)

一次性手動復甦器

K 號：K210288 · 2021-08-26

申請人Xiamen Compower Medical Tech. Co., Ltd.

決定日期2021-08-26

產品代碼BTM

諮詢委員會AN

決定相當於

器材摘要

Disposable Manual Resuscitator is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Compower Medical Tech. Co., Ltd.. It received FDA 510(k) clearance on 2021-08-26 under 510(k) number K210288. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Manual Resuscitator?

Disposable Manual Resuscitator is a medical device that received FDA 510(k) clearance on 2021-08-26. The listed applicant is Xiamen Compower Medical Tech. Co., Ltd.. The 510(k) number is K210288.

When did Disposable Manual Resuscitator receive FDA 510(k) clearance?

Disposable Manual Resuscitator received FDA 510(k) clearance on 2021-08-26, under 510(k) number K210288.

Who is the listed applicant for Disposable Manual Resuscitator?

The FDA 510(k) record lists Xiamen Compower Medical Tech. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Manual Resuscitator?

The FDA product code for Disposable Manual Resuscitator is BTM.

其他以 Xiamen Compower Medical Tech. Co., Ltd. 為申請人之記錄

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K171961Compower CPR 面罩含氧氣接口、Compower CPR 面罩不含氧氣接口、Compower 嬰兒 CPR 面罩、Compower 非再呼吸閥（22mm/15mmOD）、非再呼吸閥（22mm/18.5mm）

相關器械（代碼：BTM）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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